The digitalization of the healthcare industry has increased interest in incorporating artificial intelligence (AI) and machine learning (ML) technologies into medical devices. Over the last decade, the FDA has approved and reviewed a growing number of devices that use AI/ML across many therapeutic categories. AI/ML can also be used in developing medical devices or other FDA-regulated products. In 2021, the FDA, HQC, and MHRA mapped out 10 principles to improve AI/ML use in the UK.
CDHR is actively promulgating guidance documents impacting AI/ML technologies. The FDA’s interpretation of the four criteria in the statute would exempt devices from FDA medical device regulatory requirements. A previous draft of guidance was issued in 2018 and received significant criticism. The new draft guidance uses a secure product framework, removes risk tiers from the previous draft, and replaces the cybersecurity bill of materials. This guidance also states that cybersecurity is part of FDAs quality system regulation design control requirements.
The FDA proposed a 3-phase, 180-day transition period for devices covered by a EUA or COVID-related enforcement policy. The final guidance documents are expected this year. Michele Buenafe is a partner at Morgan Lewis’ Washington, DC office. She advises stakeholders on a broad range of healthcare regulatory, transactional, and litigation matters. Andrew Gray represents his clients in patent, trademark, copyright, and trade secret cases before state and federal trial and appellate courts across the US.
